2002/226/EC: Commission Decision of 15 March 2002 establishing special health checks for the harvesting and processing of certain bivalve molluscs with a level of amnesic shellfish poison (ASP) exceeding the limit laid down by Council Directive 91/492/EEC (Text with EEA relevance) (notified under document number C(2002) 1009)
Date: 2002-03-15
Institutions: European Commission
Subjects: European standard, dangerous substance, health control, mollusc

16.3.2002

EN

Official Journal of the European Communities

L 75/65

COMMISSION DECISION

of 15 March 2002

establishing special health checks for the harvesting and processing of certain bivalve molluscs
with a level of amnesic shellfish poison (ASP) exceeding the limit laid down by Council Directive
91/492/EEC

(notified under document number C(2002) 1009)

(Text with EEA relevance)

(2002/226/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/492/EEC of 15 July
1991 fixing the health conditions for the production and the
live bivalve molluscs (1), as last
placing on the market of
amended by Directive 97/79/EC (2), and in particular Chapter
V,

last paragraph, of the Annex thereto,

(5)

(6)

The provisions of this Decision should be re-evaluated
when scientific evidence indicates the need to introduce
other health checks, or to amend the parameters estab-
lished for the purpose of protecting public health.

The measures provided for in this Decision are in
accordance with the opinion of the Standing Veterinary
Committee,

Whereas:

HAS ADOPTED THIS DECISION:

(1)

(2)

(3)

(4)

Chapter V, point 7a, of the Annex to Directive 91/
492/EEC provides that the total amnesic shellfish poison
(ASP) content in the edible parts of molluscs (the entire
body or any part edible separately) must not exceed
20 mg/kg of domoic
acid (DA) using the high
performance liquid chromatography (HPLC) method.

For bivalve molluscs belonging to the species Pecten
maximus and Pecten jacobaeus, scientific studies have
shown that with a DA concentration in the whole body
between 20 and 250 mg/kg, under certain restrictive
conditions, the concentration of DA in the adductor
muscle and/or gonads intended for human consumption
is normally below the limit of 20 mg/kg.

In the light of recent scientific studies it is appropriate to
lay down, only for the harvesting stage and only for the
bivalve molluscs belonging to the species referred to in
recital 2, an ASP level with respect to the whole body,
higher than the limit laid down in Directive 91/492/EEC.

It is for the Competent Authority of Member States to
authorise the establishments carrying out the specific
preparation of these bivalve molluscs and to check the
satisfactory application of
the ‘own health checks’
procedures set out in Article 6 of Council Directive
91/493/EEC of 22 July 1991 laying down the health
conditions for the production and the placing on the
fishery products (3), as last amended by
market of
Directive 97/79/EC.

(1) OJ L 268, 24.9.1991, p. 1.
(2) OJ L 24, 30.1.1998, p. 31.
(3) OJ L 268, 24.9.1991, p. 15.

Article 1

1.
By way of derogation from point 7a of Chapter V of the
Annex to Directive 91/492/EEC, Member States may authorise
the harvesting of bivalve molluscs belonging to the species
Pecten maximus and Pecten jacobaeus with a concentration of
domoic acid (DA) in the whole body exceeding 20 mg/kg but
lower than 250 mg/kg which satisfy the requirements in para-
graph 2.

The requirements referred to in paragraph 1 are the

2.
following:

(a) the molluscs must be subjected to the harvesting conditions

laid down in the Annex to this Decision;

(b) they must be transported in containers or vehicles, sealed
under the direction of the competent authority, and directly
dispatched from the production areas to an approved
establishment authorised to carry out the specific prepara-
tion of these molluscs, that involves the removal of the
hepatopancreas, soft tissues, or any other contaminated
part not in compliance with point 2 of the Annex. A list of
the establishment specifically authorised must be trans-
mitted by the competent authority to the European
Commission and to Member States;

(c) they must be accompanied by a registration document,
issued by the competent authority, for each batch, speci-
fying the requirements as provided for in Chapter II, point
6, of the Annex to Directive 91/492/EEC, as well as the
anatomical part or parts that can be processed for human
consumption. A permanent transport authorisation granted
by the competent authority is not acceptable;

L 75/66

EN

Official Journal of the European Communities

16.3.2002

(d) after total removal of hepatopancreas, soft tissues and any
other contaminated part
the adductor muscle and/or
gonads intended for human consumption must not contain
an ASP level detectable by the HPLC techniques exceeding
20 mg/kg of DA.

Article 2

1.
Each batch of end product shall be tested by the specifi-
cally authorised establishment. If a sample, as defined in the
Annex, contains more than 20 mg/kg of DA the entire batch
shall be destroyed under
the competent
authority.

the control of

The hepatopancreas, soft tissues and any other toxic part
2.
the Annex
exceeding the limits laid down in point 2 of
(including the end product exceeding the limit of 20 mg/kg of
DA), shall be destroyed under the control of the competent
authority.

The competent authority shall ensure that

3.
the ‘own
health checks’ provided for in Article 6 of Directive 91/
493/EEC apply to the preparation referred to in Article 1(2)(b)

inform the competent
of this Decision. The producer shall
authority of any results relating to the end product which are
not in compliance with Chapter V point 7a of the Annex to
Directive 91/492/EEC.

Article 3

The provisions of this Decision shall be reviewed in the light of
scientific progress.

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 15 March 2002.

For the Commission

David BYRNE

Member of the Commission

ANNEX

1. No harvesting of bivalve molluscs of the species Pecten maximus and Pecten jacobaeus must be allowed during the
occurrence of an ASP active toxic episode in the waters of the production areas as established in Chapter VI, point 2,
of the Annex to Directive 91/492/EEC.

2. A restricted harvesting regime of molluscs with DA concentration in the whole body higher than 20 mg/kg can be
initiated if two consecutive analyses of samples, taken between one and no more than seven days, show that DA
concentration in whole mollusc is lower than 250 mg/kg and that the DA concentration in the parts intended for
human consumption, which have to be analysed separately, is lower than 4,6 mg/kg. The analyses of the entire body
will be performed on an homogenate of 10 molluscs. The analysis on the edible parts will be performed on an
homogenate of 10 individual parts.

3. Sampling points shall be decided by the Competent Authority to ensure that the product meets the parameters
mentioned under point 2. Once harvesting is allowed, sampling frequency for DA analysis in molluscs (whole body
and adductor muscle and gonads separately) shall be weekly as a minimum. Harvesting can continue if results are in
compliance with the conditions listed in point 2.